licensure of apheresis blood products august 15, 2007 lister hill auditorium, nih bethesda, md
DESCRIPTION
Licensure of Apheresis Blood Products Workshop The purpose of this public workshop is to educate industry on the licensure requirements and license application procedures for Platelets, Pheresis, Red Blood Cells, and Plasma collected by automated cell separator devices.TRANSCRIPT
Licensure of Apheresis Blood Products
August 15, 2007 Lister Hill Auditorium, NIH
Bethesda, MD
CBER’s VisionProtect and improve public and individual health in the United States and, where feasible, globally;
Facilitate the development, approval of, and access to safe and effective products and promising new technologies; and
Strengthen CBER as a preeminent regulatory organization for biologics.
Licensure of Apheresis Blood Products Workshop
The purpose of this public workshop is to educate industry on the licensure requirements and license application procedures for Platelets, Pheresis, Red Blood Cells, and Plasma collected by automated cell separator devices.
Licensure of Apheresis Blood Products
Workshop Co-Sponsors
• Center for Biologics Evaluation and Research, FDA
• HHS Office of the Secretary/Office of Public Health and Science
• AABB• America’s Blood Centers (ABC)
Agenda
Welcoming Remarks, Jesse Goodman, M.D., M.P.H., FDA
The Regulatory Paradigm and Managed Review, Alan E. Williams, Ph.D., FDA
FDA Review of Apheresis Submissions, Judy Ellen Ciaraldi, MT (ASCP)SBB, CQA (ASQ), FDA
Top Ten Pitfalls with Submissions, Rosia E. Nesbitt, B.S. (ASCP) SBB, CQA (ASQ), FDA
AgendaExamples of Successful Submissions
Preparing Apheresis License Submissions Stephen Kassapian, American Red Cross
Blood Systems’ Licensure of 5 and 7-Day Platelets, Kathleen Hopping, B.S., CQA (ASQ), Blood Systems, Inc.
FDA Guidance on Collection of Platelets by Automated Methods, Lore Fields, MT (ASCP) SBB, FDA
Agenda
Impact of Very Frequent Plateletpheresis on Donor Platelet Counts, Louis M. Katz, M.D., Mississippi Valley Regional Blood Center
AgendaFailure Investigations of Apheresis Blood Products
FDA Regulations and Recommendations for Failure Investigations, Hoi-may Wong, B.S., MT (ASCP) SBB, FDA
Experiences with a Failure Investigation Program for Apheresis Blood Products, Faye Kugele, M.S., MT (ASCP) SBB, CQM (ASQ), American Red Cross
Agenda
Meet Your FDA Consumer Safety Officer
AgendaDevice Manufacturer’s Forum
Merilyn Wiler, MT (ASCP) SBB, Gambro BCT
Sharyn Orton, Ph.D., Fenwal
Sue Finneran, Haemonetics
Frequently Asked Questions and Answers, Panel of FDA staff
Licensure of Apheresis Blood Products
WorkshopWorkshop Planning Committee:Celso Bianco, M.D., ABCSue Finneran, HaemoneticsJoe Giglio, M.S., MT(ASCP)SBB, AABBSteve Kassapian, ARCSharyn Orton, Ph.D., Fenwal, IncMerilyn Wiler, MT(ASCP)SBB, Gambro BCT
Workshop Planning Committee:• Alan Williams, Ph.D., Associate Director,
Regulatory Affairs• Elizabeth Callaghan, Acting Director, Division of
Blood Applications• Jennifer Scharpf, OBRR Associate Director for
Policy• Rhonda Dawson, Policy Analyst• Lore Fields MT(ASCP)SBB, Consumer Safety
Officer, Blood and Plasma Branch• Rosia Nesbitt MT(ASCP)SBB, Consumer Safety
Officer, Blood and Plasma Branch• Hoi-May Wong MT(ASCP), Consumer Safety
Officer, Blood and Plasma Branch